FDA — authorised 13 February 2009
- Application: NDA021856
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: ULORIC
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Febuxostat IR on 13 February 2009
Yes. FDA authorised it on 13 February 2009.
TAKEDA PHARMS USA holds the US marketing authorisation.